Pediatric Glaucoma, Elevated IOP in Pediatric Patients, Ocular Hypertension in Pediatric Patients
Conditions
Brief summary
The purpose of this study is to evaluate the intraocular pressure (IOP)-lowering efficacy of Travoprost 0.004% POLYQUAD (PQ) ophthalmic solution compared to Timolol ophthalmic solution (0.5% or 0.25%) in pediatric glaucoma patients.
Interventions
DRUGTravoprost 0.004% PQ ophthalmic solution
DRUGTimolol, 0.5% or 0.25% ophthalmic solution
Patients 2 months to \< 3 years of age received 0.25%
Inactive ingredients used to maintain masking
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Months to 17 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of pediatric glaucoma or ocular hypertension. * Qualifying mean IOP at the Eligibility Visit in at least one eye. * Written informed consent, including assent when applicable, MUST be obtained from the parent or legally authorized representative prior to any procedure specified in the protocol, including screening procedures. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Females of childbearing potential who are pregnant, intend to become pregnant during the study period, breast feeding, or not using any form of birth control measures. * History of chronic, recurrent or severe inflammatory eye disease. * Ocular trauma requiring medical attention within the past 3 months prior to the Screening Visit. * Ocular infection or ocular inflammation within the past 30 days prior to the Screening Visit. * Clinically significant or progressive retinal disease. * Severe ocular pathology (including severe dry eye) that, in the opinion of the Investigator, would preclude the administration of a topical prostaglandin analog or a topical beta-blocker. * Intraocular surgery in the study eye within 30 days prior to the Screening Visit. * Any abnormality preventing reliable applanation tonometry. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in IOP at Month 3 | Baseline (Day 0), Month 3 | IOP (fluid pressure inside the eye) was assessed using a calibrated tonometer and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye from each participant was chosen as the study eye and only the study eye was used for analysis. |
Participant flow
Recruitment details
Participants were recruited from 38 investigational centers in the United States, Germany, Singapore, United Kingdom, Taiwan, Philippines, Spain, Saudi Arabia, Colombia, France, Portugal, Belgium, Poland, Romania, Puerto Rico, and Mexico.
Pre-assignment details
Of the 184 enrolled, 32 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants (152).
Participants by arm
| Arm | Count |
|---|---|
| Travoprost 1 drop administered in each eye in the evening with Travoprost vehicle in the morning for 3 months | 77 |
| Timolol 1 drop administered in each eye twice daily (once in the morning and once in the evening) for 3 months; both concentrations of timolol (0.5% and 0.25%, based on age) were combined into a single group. | 75 |
| Total | 152 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Inadequate IOP control | 1 | 0 |
| Overall Study | Treatment Failure | 5 | 1 |
Baseline characteristics
| Characteristic | Total | Timolol | Travoprost |
|---|---|---|---|
| Age, Customized 12 to <18 years | 57 participants | 30 participants | 27 participants |
| Age, Customized 2 months to <3 years | 16 participants | 6 participants | 10 participants |
| Age, Customized 3 to <12 years | 79 participants | 39 participants | 40 participants |
| Intraocular Pressure | 24.4 mmHg STANDARD_DEVIATION 4.32 | 24.2 mmHg STANDARD_DEVIATION 4.01 | 24.7 mmHg STANDARD_DEVIATION 4.62 |
| Sex: Female, Male Female | 80 Participants | 40 Participants | 40 Participants |
| Sex: Female, Male Male | 72 Participants | 35 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 184 | 22 / 77 | 6 / 75 |
| serious Total, serious adverse events | 0 / 184 | 0 / 77 | 2 / 75 |
Outcome results
Primary
Mean Change From Baseline in IOP at Month 3
IOP (fluid pressure inside the eye) was assessed using a calibrated tonometer and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye from each participant was chosen as the study eye and only the study eye was used for analysis.
Time frame: Baseline (Day 0), Month 3
Population: All participants who received study drug and completed at least 1 scheduled on-therapy visit. No imputation was used, therefore the analysis included only observed cases.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Travoprost | Mean Change From Baseline in IOP at Month 3 | -5.4 mmHg | Standard Error 0.98 |
| Timolol | Mean Change From Baseline in IOP at Month 3 | -5.3 mmHg | Standard Error 0.93 |